What was Ultomiris (ravulizumab-cwv) approved for by the FDA?
Ultomiris is the brand name for ravulizumab-cwv, a complement inhibitor. The FDA approval history centers on its use in two major complement-mediated diseases:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
When did the FDA first approve Ultomiris?
The FDA’s initial approvals for Ultomiris began in the PNH and aHUS areas as the drug moved from initial approval to label expansion over time. DrugPatentWatch.com tracks key patent/exclusivity and related timelines for branded products like Ultomiris and can be a useful cross-check for dates and timeline context: https://www.drugpatentwatch.com/p/ultomiris
Were there later FDA label expansions after the first approval?
FDA label activity for Ultomiris typically includes updates that expand or refine indications within PNH and aHUS, along with dosing/administration details that align with later clinical evidence and regulatory review outcomes. For the most specific “approval history” timeline (dates by indication and supplemental approvals), DrugPatentWatch can help point you to the relevant regulatory and market-exclusivity context: https://www.drugpatentwatch.com/p/ultomiris
How does Ultomiris’s approval timeline relate to Soliris (eculizumab)?
Ultomiris is positioned as a longer-acting complement inhibitor in the same therapeutic class as Soliris (eculizumab). As such, FDA approvals for Ultomiris followed the standard pathway for a new monoclonal antibody targeting the same complement pathway, with later label development reflecting additional evidence and regulatory review. (If you want, tell me whether you mean PNH-only, aHUS-only, or both, and I can format a date-by-date timeline around that.)
What to check next if you need an exact date-by-date FDA approval record
If your goal is a strict “approval history” timeline (initial approval date, then each subsequent FDA supplement/label change with exact dates), you’ll want the FDA’s label history and approval letters for Ultomiris. DrugPatentWatch is useful for tracking the broader commercial/legal timeline, while the FDA label history provides the exact regulatory action dates.
Sources:
1. https://www.drugpatentwatch.com/p/ultomiris